Nicotine Patches
- Product NDC
- 85333-005
- 11-digit product format
- 853330005
- Labeler code
- 85333
- Product ID
- 85333-005_4d46110b-5aa8-5261-e063-6394a90a423a
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Nicotine Patches
- Dosage form
- PATCH
- Route
- TRANSDERMAL
- Labeler
- Zhejiang FTA Shengzuozhi Biotechnology Co., LTD
- Application
- M016
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2026-03-18
- Substance
- NICOTINE
- Active strength
- 7 mg/7mg
- Pharmacologic classes
- Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Nicotine Patches
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| NICOTINE | 7 mg/7mg |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 6M3C89ZY6R | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 198031 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 4d46110b-5aa7-5261-e063-6394a90a423a | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| dbebfdf8-6e0c-cfa8-fdbc-e5d7f1bf1562 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 85333-005-02 | Nicotine Patches | 21 mg in 1 PATCH | PATCH | 21 | 1 | |
| 85333-005-02 | Nicotine Patches | 14 in 1 BOX | PATCH | 14 | 1 |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Petroleum | WHITE PETROLATUM | Harris Teeter | de380df6-cc6e-4b2a-98de-fc08eeb6e8ea | 2026-02-04 | Warnings, Adverse reactions | M016 |
| Petroleum | WHITE PETROLATUM | Hy-Vee, Inc. | 45867f42-9562-c111-e063-6394a90adb70 | 2026-02-04 | Warnings, Adverse reactions | M016 |
| Daily Moisturizing | DIMETHICONE | Lidl US, LLC | c82f236d-c27f-458c-bcd8-19877d09e9a3 | 2026-02-04 | Warnings, Adverse reactions | M016 |
| Daily Moisturizing | DIMETHICONE | Lidl US, LLC | 5e83811f-773f-43e7-bab8-f9e558fb0e00 | 2026-02-04 | Warnings, Adverse reactions | M016 |
| Calamine | FERRIC OXIDE RED | Major Pharmaceuticals | c25be68d-834a-4959-8d47-01ec789406ba | 2026-02-04 | Warnings, Adverse reactions | M016 |
| Petroleum Skin Protectant | WHITE PETROLATUM | Major Pharmaceuticals | 0e7e11c5-a1f8-43c4-b8a6-211491052404 | 2026-02-04 | Warnings, Adverse reactions | M016 |
| Witch Hazel | WITCH HAZEL | EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC) | d76e116f-4b22-4633-8487-17ad3b5778c7 | 2026-02-04 | Warnings | M016 |
| Comforts Petroleum Jelly | WHITE PETROLATUM | KROGER | 3feb3638-1cdc-62d4-e063-6294a90a1d89 | 2026-02-03 | Warnings | M016 |
| Daily Moisturizing | DIMETHICONE | CVS Pharmacy, Inc. | edc20df4-561e-486f-b9f1-900672a0f2a4 | 2026-02-03 | Warnings, Adverse reactions | M016 |
| Colloidal oatmeal | COLLOIDAL OATMEAL | CVS Pharmacy, Inc. | a153842c-d9ce-4658-912b-362a6f20b0aa | 2026-02-03 | Warnings, Adverse reactions | M016 |
| Petroleum Skin Protectant | WHITE PETROLATUM | Demoulas Super Markets, Inc | 702215f0-4cfd-4a23-b47a-da691c136634 | 2026-02-03 | Warnings, Adverse reactions | M016 |
| Neurexa | COLLOIDAL OATMEAL | METHODIQ INC. | 494d7915-acad-260e-e063-6394a90a182c | 2026-02-03 | Warnings | M016 |
| Thera Plus Vitamin A and D Cream | DIMETHICONE, ZINC OXIDE | FOURSTAR GROUP USA, INC. | 36f09fa4-a3b8-4104-9745-ee60aa493b06 | 2026-02-02 | Warnings | M016 |
| Vitamin A D | LANOLIN, PETROLATUM | Kroger Co. | b4aa9b58-d95e-4dac-9a34-213482e8ca34 | 2026-02-02 | Warnings, Adverse reactions | M016 |
| Nail Nourishing Pen | GLYCERIN | Shantou Ximonth Biotechnology Co., Ltd. | 49e45462-a05f-d370-e063-6394a90a1e0f | 2026-02-02 | Warnings | M016 |
| Barrier Repair Cream | CREAM | Steel City Health Private Limited | 4842f653-7137-eca4-e063-6394a90a8c55 | 2026-01-31 | Warnings | M016 |
| Cracked Heel Repair Balm | DIMETHICONE | Delta Brands Inc. | 42b7c9f8-0557-8e33-e063-6394a90a5919 | 2026-01-30 | Warnings | M016 |
| Readybath TPC Total Perineal Care | DIMETHICONE | Medline Industries, Inc. | 43a3f0f7-f76f-434d-a21f-7eaa3638913d | 2026-01-30 | Warnings | M016 |
| Lanolin, Petrolatum | LANOLIN, PETROLATUM | Rite Aid Corporation | 1b6d7cdf-e7bc-4fd4-939c-5eb0eaa1744d | 2026-01-30 | Warnings, Adverse reactions | M016 |
| Zinc Oxide | ZINC OXIDE | Rite Aid Corporation | 3af9f0e5-0d79-4178-b29e-3b60735bf4ce | 2026-01-30 | Warnings, Adverse reactions | M016 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 198031 | nicotine 7 MG/Day 24HR Transdermal System | PSN | 4d46110b-5aa7-5261-e063-6394a90a423a | 1 |
| 198031 | 24 HR nicotine 0.292 MG/HR Transdermal System | SCD | 4d46110b-5aa7-5261-e063-6394a90a423a | 1 |
| 198031 | nicotine 0.292 MG/HR 24HR Transdermal Patch | SY | 4d46110b-5aa7-5261-e063-6394a90a423a | 1 |
| 198031 | nicotine 7 MG per 24HR 1 Day Transdermal Patch | SY | 4d46110b-5aa7-5261-e063-6394a90a423a | 1 |
| 198031 | nicotine 7 MG/Day 24HR Transdermal System | SY | 4d46110b-5aa7-5261-e063-6394a90a423a | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 85333-005-02 | 85333000502 | 14 PATCH in 1 BOX (85333-005-02) / 21 mg in 1 PATCH | 14 patch | 2026-03-18 | No | No | Current |